Catalog Number 320-11-00 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2016.Revision due to patient having recurrent dislocations since (b)(6) 2017.The case report indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.\ the revision reported was likely the result of recurrent dislocations, which is addressed in the product labeling under device specific risks.The surgeon states that the event was "unlikely related" to the devices.
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Event Description
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Index surgery: (b)(6) 2016.Revision due to patient having recurrent dislocations since (b)(6) 2017.The case report indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
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Search Alerts/Recalls
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